In search of hope, help for heart November 26, 2006

Posted by TheraVitae in : VesCell in the News , trackback

Stephanie Miller had bypass surgery, and doctors twice propped her clogged arteries open with stents.

Still, the 54-year-old Madison woman’s heart deteriorated. Her cardiologist said she risked an early death.

Miller, not willing to give up, sought help far away: She traveled to Thailand for an experimental stem-cell therapy.

A real estate broker and mother of four, she paid $35,000 to have stem cells from her blood implanted into arteries around her heart. It’s too soon to know if the procedure helped.

“You stay home and die or you go there and try,” Miller said after returning this month from Bangkok.

She joined the growing ranks of Americans pursuing medical tourism. Most go oversees for plastic surgery or routine operations at cut-rate prices.

Miller took her international journey to ensure she would get stem cells.

She could have enrolled in studies of similar treatments in the United States, including one starting at UW Hospital. But she might have received a fake treatment; most U.S. studies give placebos to some patients to see if the real treatment works better.

“I didn’t want to take a chance that I wouldn’t get the real thing,” Miller said.

Though the stem-cell therapy she received has not been proven through rigorous research trials to work, it has a low risk of side effects, said Dr. Tamara Hagen, a UW Health cardiologist.

Hagen, Miller’s doctor, approved of the trip.

“I don’t know whether it’s going to benefit her or not, but it is a promising therapy,” Hagen said.

Miller, who has diabetes, didn’t have heart problems until August 2005. Pain in her chest and arm led her to undergo a test that showed that several arteries around her heart were clogged.

She had triple-bypass surgery at UW Hospital. A few months later, the symptoms returned. Doctors performed angioplasty, clearing her arteries with a catheter and propping them open with wire-mesh stents.

Again the symptoms came back. Again she had stent angioplasty.

But Miller’s coronary artery disease was aggressive, Hagen said, and the symptoms continued. The doctor, who prescribed beta-blockers, statins and other drugs, said Miller likely would face more surgery or angioplasty - and a shortened lifespan.

Miller searched the Internet and found TheraVitae, a company offering stem-cell therapy in Thailand.

The process begins when a half pint of blood is drawn from the patient. The blood is flown to a TheraVitae lab in Israel, where stem cells are harvested and multiplied. The cells are flown back to Bangkok, where millions of them are injected through a catheter into coronary arteries around the patient’s heart.

The therapy uses “adult” stem cells. It doesn’t involve the controversial embryonic stem cells, first isolated at UW- Madison, that require the destruction of days-old embryos leftover from fertility clinics.

Adult stem cells are considered safer for use in cell therapies than embryonic stem cells because they are less likely to form tumors. But they may be less effective, scientists say.

Exactly how stem-cell therapy might help patients with heart disease isn’t clear. Scientists say the cells might create new blood vessels, grow new heart muscle or release helpful chemicals known as growth factors.

TheraVitae, which treated Hawaiian crooner Don Ho a year ago, says its treatment can reduce chest pain and allow patients to become more active. Results may not be noticed for several months, the company’s Web site says.

In a study reported at an American Heart Association meeting last week in Chicago, TheraVitae doctors said 75 percent of patients had improved blood flow six months after treatment and 90 percent of patients could exercise more.

The study involved only 24 patients and didn’t include placebos. Company officials did not respond to requests for an interview.

Dr. Amish Raval, a UW Health cardiologist, is heading up a new study of a similar treatment at UW Hospital.

It also uses adult stem cells from a patient’s blood. But the blood will be retrieved and processed differently, and the cells will be injected directly into the heart muscle, not into coronary arteries.

The study, based in Boston, will recruit about 15 patients at UW Hospital. Some might get a placebo.

Other U.S. medical centers are also offering such studies, Raval said. Some trials have shown a benefit to patients, while others haven’t.

Raval said it’s important to study stem-cell therapy for heart disease carefully before offering it routinely as is being done in Thailand.

“I think it’s going to be safe, but it’s expensive,” he said. “We don’t have enough proof that these cells are providing improvements in heart function to go to Thailand and expect a positive result.”

Miller said she didn’t have time to wait until U.S. doctors studied the therapy enough for the Food and Drug Administration to consider approval.

“I don’t want the government making health-care decisions for me,” she said. “I can make my own.”

A self-described “Type A” personality, Miller said she was impressed with her experience in Thailand - from the luxurious hotel and the spacious hospital room to the attentive staff.

“They were all so professional,” she said.

She and her husband, Jim Stellhorn, left Madison Oct. 20. They returned Nov. 8, a week after she received the cells. The couple spent about $5,000 on travel and food in addition to the $35,000 for the therapy.

The trip included some sightseeing, including an elegant dinner and a river festival.

“You work your whole life,” Miller said. “What’s the money worth if you can’t get healthy and live longer?”

She will visit Hagen for checkups to see if the therapy helps.

Miller said she wants to see her six grandchildren, ages 3 to 13, grow up.

“I feel like something is happening inside me,” she said. “I hope I get 10 or 20 more years.”

Stem-cell therapy for treating heart disease U.S. medical centers, including UW Hospital, are studying the use of “adult” stem cells to treat heart disease. Companies in other countries such as Thailand are already offering the therapy, often at great expense.

For more information, visit these Web sites:

TheraVitae Web Site : www.theravitae.com
VesCell Web Site : www.vescell.com